Evaluation and development of a novel binocular treatment (I-BiT™) system using video clips and interactive games to improve vision in children with amblyopia (‘lazy eye’): study protocol for a randomised controlled trial

Abstract

BackgroundAmblyopia (lazy eye) affects the vision of approximately 2% of all children. Traditional treatment consists of wearing a patch over their ‘good’ eye for a number of hours daily, over several months. This treatment is unpopular and compliance is often low. Therefore results can be poor. A novel binocular treatment which uses 3D technology to present specially developed computer games and video footage (I-BiT™) has been studied in a small group of patients and has shown positive results over a short period of time. The system is therefore now being examined in a randomised clinical trial.Methods/designSeventy-five patients aged between 4 and 8 years with a diagnosis of amblyopia will be randomised to one of three treatments with a ratio of 1:1:1 - I-BiT™ game, non-I-BiT™ game, and I-BiT™ DVD. They will be treated for 30 minutes once weekly for 6 weeks. Their visual acuity will be assessed independently at baseline, mid-treatment (week 3), at the end of treatment (week 6) and 4 weeks after completing treatment (week 10). The primary endpoint will be the change in visual acuity from baseline to the end of treatment. Secondary endpoints will be additional visual acuity measures, patient acceptability, compliance and the incidence of adverse events.DiscussionThis is the first randomised controlled trial using the I-BiT™ system. The results will determine if the I-BiT™ system is effective in the treatment of amblyopia and will also determine the optimal treatment for future development.Trial registrationClinicalTrials.gov identifier: NCT01702727

Randomised controlled trial of video clips and interactive games to improve vision in children with amblyopia using the I-BiT system

“…16 The study was a randomised parallel group design with the intention to recruit 75 patients. The eligible patients were randomised to one of three treatments.…”

“…For full list of inclusion and exclusion criteria, see the protocol paper. 16 Interventions I-BiT shutter glasses system…”

A binocular iPad treatment for amblyopic children

“…An interactive binocular treatment, the I-BiT, has also been described. [21][22][23][24] The I-BiT presents equal-contrast central stimuli to the amblyopic eye and peripheral stimuli to the fellow eye. A pilot study on nine children who used the I-BiT for 30 min per week for 6 weeks reported that six had 0.125 logMAR or more improvement in visual acuity but had no control group.…”

Évaluation d’une plateforme d’orthoptie numérique 3D

“…La numérisation de ces tests peut permettre d'améliorer les conditions de travail des orthoptistes, proposer des tests originaux avec une précision accrue, rendre les examens plus rapides et pourquoi pas, permettre une large autonomie du patient. Seuls quelques tests orthoptiques numériques sont disponibles sur le marché de nos jours [2] tandis que d'autres ne sont que des prototypes [3][4][5][6][7][8][9][10]. La société Orthoptica ® développe des tests oculomoteurs sur une plateforme numérique utilisant un dérivé de la technologie du cinéma 3D en utilisant en écran, un projecteur et des lunettes actives [11].…”